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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90411
Device Problem Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2019
Event Type  malfunction  
Event Description
No patient was involved in this event.It was reported the centrimag 2nd generation primary console and motor displayed an m3 pump not inserted alarm.The product will be returned for evaluation.No additional information was provided.
 
Event Description
Additional information from the clinician reported before this incident, the perfusion team had not reported any previous problems with the equipment.No patient was involved with the event.No additional information was provided.
 
Manufacturer Narrative
Section d3, g2: correction.
 
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Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ  CH-8005
MDR Report Key8315346
MDR Text Key137013490
Report Number2916596-2019-00461
Device Sequence Number1
Product Code DWA
UDI-Device Identifier07640135140702
UDI-Public07640135140702
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number201-90411
Device Catalogue Number201-90411
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2019
Was the Report Sent to FDA? No
Date Manufacturer Received02/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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